Taiwan FDA registration a0bcf84b22fd6f6ceae821ed5ec3d0e2

"Earlink" Air Conduction Hearing Aid (Non-Sterile)

TW: "宜林" 氣導式助聽器 (未滅菌)

Taiwan·Risk Class 1·MD·SIVANTOS PTE. LTD·Registered Dec 12, 2017 – Dec 12, 2027Active

Registration details

Analysis ID: a0bcf84b22fd6f6ceae821ed5ec3d0e2
License Form: Ministry of Health Medical Device Import No. 018599
Customs Code: DHA09401859906

Company information

Manufacturer: SIVANTOS PTE. LTD
Manufacturer Country: Singapore
Authorized Representative: EARLINK TECHNOLOGY CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Hearing Aids (G.3300)".
Product Type (Level 1): G ENT device
Product Type (Level 2): G3300 hearing aid
Import Information: Imported from abroad

Dates and status

Registration Date: Dec 12, 2017
Expiry Date: Dec 12, 2027

About this record

Access comprehensive regulatory information for "Earlink" Air Conduction Hearing Aid (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a0bcf84b22fd6f6ceae821ed5ec3d0e2 and manufactured by SIVANTOS PTE. LTD. The authorized representative in Taiwan is EARLINK TECHNOLOGY CO., LTD..

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